MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM

Model Number	1.86
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no report of patient harm or any intervention required.There currently is a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Event or Problem Description
The customer indicated that their statstrip wireless meter, serial number: (b)(4) reported glucose results that did not match glucose results from abl825 blood gas.Patient was born at 22 weeks and 2 days gestation and was receiving continuous iv nutrition (tpn, dextrose, lipids).Nursing questioned the results based on other lab values; specifically the glucose from the abl.Patient was already in critical condition with sepsis adn passed on 10/13, however, the meter result was not used in any care decisions as per the customer.
Additional Manufacturer Narrative
An investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.
Additional Manufacturer Narrative
Additional information: b4, b5, d9, g3, g6, h2, h3, h4, h6 and h10.Udi: (b)(4).The customer indicated that the samples that were reported on their statstrip wireless meter, serial number: (b)(6) with test strip lot: 0321033249, did not match glucose results from abl825 blood gas.The event was observed on (b)(6), 2021.The same patient sample was run on abl825 and reported higher glucose reading at 345mg/dl while the statstrip wireless meter reported 272mg/dl.Customer reported that patient was already in critical condition with sepsis and passed on (b)(6), however, the meter result was not used in any care decisions.Dhr reviews for the statstrip 1.86 meter, sn (b)(6), and statstrip glucose test strips, lot 0321033249, were performed by a quality control engineer.Dhr reviews for statstrip glucose control solution level 1, lot 0421139301, and level 3, lot 0421175303, were performed by a quality control manager.The reviews included an assessment of the production, testing, and release of the meter, test strip batch, and control solutions.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.Retained statstrip glucose test strips, lot 0321033249, met all performance acceptance criteria for whole blood and linearity testing.Returned statstrip glucose test strips, lot 0321033249, met all performance acceptance criteria for whole blood testing.Linearity testing on the returned test strips was not possible because the customer did not return enough strips.There were no discrepant, low, glucose results observed during testing of returned or retained statstrip glucose test strips, lot 0321033249, or on the returned nova statstrip glucose meter, sn (b)(6).The customer's complaint could not be duplicated.No other similar issues have been reported and no further action is required at this time.Nova will continue to monitor for any recurring events.
Event or Problem Description
The customer indicated that their statstrip wireless meter, serial number: (b)(6), reported glucose results that did not match glucose results from abl825 blood gas.Patient was born at 22 weeks and 2 days gestation and was receiving continuous iv nutrition (tpn, dextrose, lipids).Nursing questioned the results based on other lab values; specifically the glucose from the abl.Patient was already in critical condition with sepsis and passed on (b)(6), however, the meter result was not used in any care decisions as per the customer.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer Contact: shalomy mathew ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 12759923
• Report Number: 1219029-2021-00047
• Device Sequence Number: 4326212
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1.86
• Device Catalogue Number: 54802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 12/22/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/02/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 4 DA
• Patient Sex: Female